U.S. patent number 10,688,277 [Application Number 15/273,749] was granted by the patent office on 2020-06-23 for guide extension catheter with perfusion openings.
This patent grant is currently assigned to Medtronic Vascular, Inc.. The grantee listed for this patent is Medtronic Vascular, Inc.. Invention is credited to Michael Donegan, Michael Morrissey, Barry O'Connell, John Tuohy, Sean Ward.
![](/patent/grant/10688277/US10688277-20200623-D00000.png)
![](/patent/grant/10688277/US10688277-20200623-D00001.png)
![](/patent/grant/10688277/US10688277-20200623-D00002.png)
![](/patent/grant/10688277/US10688277-20200623-D00003.png)
![](/patent/grant/10688277/US10688277-20200623-D00004.png)
![](/patent/grant/10688277/US10688277-20200623-D00005.png)
![](/patent/grant/10688277/US10688277-20200623-D00006.png)
![](/patent/grant/10688277/US10688277-20200623-D00007.png)
![](/patent/grant/10688277/US10688277-20200623-D00008.png)
![](/patent/grant/10688277/US10688277-20200623-D00009.png)
![](/patent/grant/10688277/US10688277-20200623-D00010.png)
View All Diagrams
United States Patent |
10,688,277 |
O'Connell , et al. |
June 23, 2020 |
Guide extension catheter with perfusion openings
Abstract
A guide extension catheter includes a proximal shaft, a distal
shaft, and a plurality of perfusion openings. The distal shaft
includes a jacket and a helical coil structure embedded in the
jacket, the distal shaft defining a lumen. The plurality of
perfusion openings are disposed though the jacket of the distal
shaft between windings of the helical coil structure. The guide
extension catheter provides additional back support to the guide
catheter. The plurality of perfusion openings allow fluid
communication between an area outside the guide extension catheter
and the lumen.
Inventors: |
O'Connell; Barry (Galway,
IE), Morrissey; Michael (Galway, IE), Ward;
Sean (Dublin, IE), Tuohy; John (Glare,
IE), Donegan; Michael (Galway, IE) |
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic Vascular, Inc. |
Santa Rosa |
CA |
US |
|
|
Assignee: |
Medtronic Vascular, Inc. (Santa
Rosa, CA)
|
Family
ID: |
58387349 |
Appl.
No.: |
15/273,749 |
Filed: |
September 23, 2016 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20170080178 A1 |
Mar 23, 2017 |
|
US 20190151607 A9 |
May 23, 2019 |
|
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
62222556 |
Sep 23, 2015 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
25/007 (20130101); A61M 25/0045 (20130101); A61M
25/005 (20130101); A61M 25/0662 (20130101); A61M
25/01 (20130101); A61M 2025/0057 (20130101); A61M
2025/0175 (20130101); A61M 2025/0004 (20130101); A61M
2025/0073 (20130101); A61M 2025/0681 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61M 25/06 (20060101); A61M
25/01 (20060101) |
Field of
Search: |
;604/527 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
102510763 |
|
Jun 2012 |
|
CN |
|
203208504 |
|
Sep 2013 |
|
CN |
|
203263993 |
|
Nov 2013 |
|
CN |
|
104185490 |
|
Dec 2014 |
|
CN |
|
104602718 |
|
May 2015 |
|
CN |
|
104768603 |
|
Jul 2015 |
|
CN |
|
104812420 |
|
Jul 2015 |
|
CN |
|
104902950 |
|
Sep 2015 |
|
CN |
|
105163789 |
|
Dec 2015 |
|
CN |
|
0537985 |
|
Mar 1997 |
|
EP |
|
0810003 |
|
Dec 1997 |
|
EP |
|
2015509030 |
|
Mar 2015 |
|
JP |
|
5770105 |
|
Aug 2015 |
|
JP |
|
2015523186 |
|
Aug 2015 |
|
JP |
|
2015524737 |
|
Aug 2015 |
|
JP |
|
2015525636 |
|
Sep 2015 |
|
JP |
|
2015525638 |
|
Sep 2015 |
|
JP |
|
2015526159 |
|
Sep 2015 |
|
JP |
|
2015526160 |
|
Sep 2015 |
|
JP |
|
2016517320 |
|
Jun 2016 |
|
JP |
|
WO2013/070758 |
|
May 2013 |
|
WO |
|
WO2013/116521 |
|
Aug 2013 |
|
WO |
|
WO2014/011677 |
|
Jan 2014 |
|
WO |
|
WO2014/012049 |
|
Jan 2014 |
|
WO |
|
WO2014/015308 |
|
Jan 2014 |
|
WO |
|
WO2014015062 |
|
Jan 2014 |
|
WO |
|
WO2014/022310 |
|
Feb 2014 |
|
WO |
|
WO2014/028898 |
|
Feb 2014 |
|
WO |
|
WO2014/037836 |
|
Mar 2014 |
|
WO |
|
WO2014/043694 |
|
Mar 2014 |
|
WO |
|
WO2014/133897 |
|
Sep 2014 |
|
WO |
|
WO2014/152191 |
|
Sep 2014 |
|
WO |
|
Other References
Brochure, Boston Scientific Guidezilla, Guide Extension Catheter,
2014. cited by applicant .
Brochure, Vascular Solution, Inc., GuideLiner V3, 2013. cited by
applicant .
PCT/US2016/053253, The International Search Report and the Written
Opinion of the International Searching Authority, dated Dec. 5,
2016. cited by applicant .
Communication Pursuant to Rules 161(1) and 162 EPC dated May 3,
2018, from counterpart European Application No. 16774815.1, 3 pp.
cited by applicant .
Response to Communication pursuant to 161(1) and 162 EPC dated May
3, 2018, from counterpart European Application No. 16774815.1,
filed Nov. 5, 2018, 22 pp. cited by applicant .
First Office Action, and English translation thereof, from
counterpart Chinese Application No. 201680054973.0, dated Mar. 20,
2020, 27 pp. cited by applicant.
|
Primary Examiner: Flick; Jason E
Attorney, Agent or Firm: Shumaker & Sieffert, P.A.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit under 35 U.S.C. .sctn. 119(e)
of the filing date of U.S. Provisional Application No. 62/222,556
filed Sep. 23, 2015.
Claims
What is claimed is:
1. A guide extension catheter, comprising: a proximal shaft having
a first dimension at a distal end; a distal shaft coupled to the
proximal shaft at a transition joint, a proximal portion of the
distal shaft having a second dimension greater than the first
dimension, and the distal shaft including a jacket and a helical
coil structure embedded in the jacket, the distal shaft defining a
lumen; and a plurality of perfusion openings disposed through the
jacket between windings of the helical coil structure, the
plurality of perfusion openings extending along the distal shaft
from a section adjacent the transition joint to a section adjacent
a distal end of the distal shaft, wherein the guide extension
catheter is configured to extend through a guide catheter such that
the guide extension catheter provides additional back support to
the guide catheter, and wherein the plurality of perfusion openings
are configured to allow fluid communication between an area outside
the guide extension catheter and the lumen.
2. The guide extension catheter of claim 1, wherein at least one
perfusion opening of the plurality of perfusion openings is
circular.
3. The guide extension catheter of claim 1, wherein at least one
perfusion opening of the plurality of perfusion openings is oval in
shape.
4. The guide extension catheter of claim 1, wherein the length
and/or width of each perfusion opening of the plurality of
perfusion openings is less than or equal to 0.5 mm.
5. The guide extension catheter of claim 1, wherein a first portion
of the plurality of perfusions are disposed through the jacket in a
distal portion of the distal shaft, the distal portion comprising
the distal end of the distal shaft, and a second portion of the
plurality of perfusions are disposed through the jacket in the
proximal portion of the distal shaft, the proximal portion
comprising a proximal end of the distal shaft.
6. The guide extension catheter of claim 1, wherein some of the
plurality of perfusion openings are grouped closely together such
that some of the plurality of perfusion openings are more
concentrated at a location of the distal shaft than other perfusion
openings of the plurality of perfusion openings at other locations
along the distal shaft.
7. The guide extension catheter of claim 1, wherein the plurality
of perfusion openings of the distal shaft are arranged in a spiral
distribution pattern.
8. The guide extension catheter of claim 1, wherein the plurality
of perfusion openings are arranged along a common longitudinal axis
of the distal shaft.
9. A guide extension catheter, comprising: a proximal shaft having
a first dimension at a distal end; a distal shaft coupled to the
proximal shaft at a transition joint, a proximal portion of the
distal shaft having a second dimension greater than the first
dimension, and the distal shaft including a jacket and a braided
structure embedded in the jacket, the braided structure having a
plurality of wire members woven together to form the braided
structure, the distal shaft defining a lumen; and a plurality of
perfusion openings disposed through the jacket between wire members
of the braided structure, the plurality of perfusion openings
extending along the distal shaft from a section adjacent the
transition joint to a section adjacent a distal end of the distal
shaft, wherein the guide extension catheter is configured to extend
through a guide catheter such that the guide extension catheter
provides additional back support to the guide catheter, and wherein
the plurality of profusion openings are configured to allow fluid
communication between an area outside the guide extension catheter
and the lumen.
10. The guide extension catheter of claim 9, wherein at least one
perfusion opening of the plurality of perfusion openings is a
circle.
11. The guide extension catheter of claim 9, wherein at least one
perfusion opening of the plurality of perfusion openings is oval in
shape.
12. The guide extension catheter of claim 9, wherein the length
and/or width of each perfusion opening of the plurality of
perfusion openings is less than or equal to than 0.5 mm.
13. The guide extension catheter of claim 9, wherein the distal
shaft includes more perfusion openings at a distal portion of the
distal shaft than at the proximal portion of the distal shaft such
that the distal portion of the distal shaft is more flexible than
the proximal portion of the distal shaft.
14. The guide extension catheter of claim 9, wherein some of the
plurality of perfusion openings are grouped together such that some
of the plurality of perfusion openings are more concentrated at a
location of the distal shaft than other perfusion openings of the
plurality of perfusion openings at other locations along the distal
shaft.
15. The guide extension catheter of claim 9, wherein the plurality
of perfusion openings of the distal shaft are arranged in a spiral
distribution pattern.
16. The guide extension catheter of claim 9, wherein the plurality
of perfusion openings of the distal shaft are arranged along a
common longitudinal axis of the distal shaft.
17. A guide extension catheter, comprising: a proximal shaft having
a first dimension at a distal end; and a distal shaft coupled to
the proximal shaft at a transition joint, a proximal portion of the
distal shaft having a second dimension greater than the first
dimension, and the distal shaft including a braided jacket, the
braided jacket having a plurality of wire members woven together to
form the braided jacket, the distal shaft defining a lumen; wherein
the plurality of wire members are woven together such that a
plurality of perfusion openings are formed between the wire
members, wherein the plurality of perfusion openings extend from an
outer surface of the distal shaft to the lumen of the distal shaft,
and wherein perfusion openings of the plurality of perfusion
openings are distributed along the distal shaft from a section
adjacent the transition joint to a section adjacent a distal end of
the distal shaft, wherein the guide extension catheter is
configured to extend through a guide catheter such that the guide
extension catheter provides additional back support to the guide
catheter, and wherein the plurality of perfusion openings are
configured to allow fluid communication between an area outside the
guide extension catheter and the lumen.
18. The guide extension catheter of claim 17, wherein at least one
perfusion opening of the plurality of perfusion openings is
generally a quadrilateral.
19. The guide extension catheter of claim 17, wherein the length
and/or width of each perfusion opening of the plurality of
perfusion openings is less than or equal to 0.5 mm.
20. The guide extension catheter of claim 17, wherein the plurality
of wire members include a coating, wherein the coating is disposed
on the plurality of wire members prior to the wire members being
woven.
21. The guide extension catheter of claim 17, wherein the distal
shaft further comprises a distal tip at the distal end of the
distal shaft.
22. The guide extension catheter of claim 1, wherein the proximal
shaft comprises a wire or a hypotube having the first dimension at
the distal end.
23. The guide extension catheter of claim 13, wherein the proximal
portion of the distal shaft includes the transition joint.
Description
FIELD OF THE INVENTION
The present invention relates to a guide extension catheter for use
with a guide catheter. More particularly, the present invention
relates to a guide extension catheter with perfusion openings for
providing blood flow distal of the guide extension catheter and
reducing dampening of the blood pressure wave in the guide
catheter.
BACKGROUND
Arteries of the heart, and more specifically coronary arteries, may
sometimes be occluded or narrowed by atherosclerotic plaques or
other lesions. These afflictions are generally referred to as
coronary heart disease or a stenosis, and result in inadequate
blood flow to distal arteries and tissue. Heart bypass surgery may
be a viable surgical procedure for certain patients suffering from
coronary heart disease. However, attendant with traditional open
surgery, significant patient trauma, discomfort, extensive
recuperation times, and life threatening complications may occur
due the invasive nature of the surgery and the necessity for
stoppage of the heart during such a surgery.
To address these concerns, efforts have been made to perform
interventional cardiology procedures using minimally invasive
techniques. In certain efforts, percutaneous transcatheter (or
transluminal) delivery and implantation of interventional coronary
devices are employed to solve the problems presented by traditional
open surgery. Typically, a guide catheter is first inserted through
an incision into a femoral (transfemoral), or radial (transradial)
artery of a patient. Transradial access is increasingly accepted as
a method offering lower post-operative bleeding complications and
quicker recovery times for patients. However the smaller diameter
of the radial artery requires a smaller diameter guide catheter.
The smaller diameter guide catheter has less back support than a
similarly configured femoral guide catheter. For example, the
Seldinger technique may be utilized in either method for
percutaneously introducing the guide catheter. In such methods, the
guide catheter is advanced through the aorta and inserted into the
opening of an ostium of a coronary artery. A guidewire, or other
interventional devices, such as a stent or balloon may be
introduced through the guide catheter and maneuvered/advanced
through the vasculature and the stenosis of the diseased coronary
artery. However, when attempting to pass through a difficult
stenosis, or when conducting a radial intervention using a small
diameter guide catheter, the guide catheter may not have adequate
back support, and continued application of force to advance the
interventional device though the stenosis may cause the distal end
of the guide catheter to dislodge from the opening of the ostium of
the coronary artery, resulting in potential damage to the
surrounding tissue.
In order to prevent the guide catheter from dislodging,
interventional cardiologists sometimes would deep seat the guide
catheter into the coronary artery. The term "deep seat or "deep
seating" means that guide catheter would be pushed farther
downstream into the coronary artery. However, deep seating the
guide catheter risks the guide catheter damaging the coronary
artery wall (dissection or rupture), occluding the coronary artery,
and interfering with blood flow to the coronary artery.
One attempt to provide additional back support to a guide catheter
that has gained acceptance is the use of a guide extension
catheter. The guide extension catheter is deployed within a lumen
of the guide catheter and extends distally from the distal end of
the guide catheter into the coronary artery. Their smaller size
(compared to the guide catheter) allows the guide extension
catheter to be seated more deeply in the coronary artery with less
potential damage. This provides additional back support to the
guide catheter to aid in delivery of interventional devices. In
cases with a difficult stenosis or radial interventions, the use of
the guide extension catheter reduces the risk of dislodging the
guide catheter from the opening of the ostium of the coronary
artery during treatment.
Because conventional guide extension catheters are used to provide
support for guide catheters, such guide extension catheters must be
structurally sound. Thus, distal portions of such guide extension
catheters conventionally include a wire support or braid, as
described in more detail below, to provide strength to the guide
extension catheter. It is not desirable to weaken such guide
extension catheters. Conventional guide extension catheters are
also designed to be smooth such that they can be advanced through
tortuous and calcified arteries. Thus, it is not desirable to
increase friction of conventional guide extension catheters.
Contrast solution is sometimes injected through the guide catheter
and guide extension catheter into the coronary artery. It is not
desirable for such contrast solution to be lost into the aorta
instead of injected into the coronary artery.
Further, even with its smaller size, when deep-seated, the guide
extension catheter may occlude the coronary artery. This will
interfere with blood flow through the coronary artery and dampen
the AO pressure wave measured proximally down the guide
catheter.
In particular, during a procedure, the guide catheter fills with
blood. A pressure sensor is disposed outside the body and measures
blood pressure at the distal end of the guide catheter through the
fluid column which fills the guide catheter. Thus, changes in blood
pressure at the distal end of the guide catheter propagate through
the guide catheter and are measured by the pressure sensor at the
proximal end of the guide catheter. However, using a guide
extension catheter deep seated in the coronary artery may interfere
with blood flow at the coronary artery. Such interference affects
the blood pressure measurement at the proximal end of the guide
catheter. Specifically, the blood pressure wave is dampened. As
explained in more detail below, the measured systolic pressure and
measured diastolic pressure both decrease. Further, both decrease
such that the normal blood pressure wave flattens or dampens such
that it is less like a wave and more like a flat line. This
dampened blood pressure wave indicates that blood flow at the
distal end of the guide extension catheter has been disrupted. This
dampened blood pressure wave also indicates that blood flow to
arteries distal of the guide extension catheter has been disrupted,
(i.e. reduced) which endangers the patient.
Due to the risks described above, use of a guide extension catheter
may result in a sense of urgency on the part of the interventional
cardiologist to complete the procedure quickly, which can result in
additional complications.
In order to avoid some of these complications, instructions for use
of conventional guide extension catheters instruct that the guide
extension catheter is to be inserted into vessels significantly
larger than the guide extension catheter. For example, instructions
for use for a conventional 6 French guide extension catheter (outer
diameter of approximately 1.75 mm) states that the product is not
to be inserted into arteries with a diameter of less than 2.5
mm.
However, in use and despite the instructions for use, the
complications described above persist. Accordingly, there exists a
need for an improved guide extension catheter design that provides
the needed additional back support to the guide catheter and
reduces dampening of the AO pressure wave within the guide
catheter, while minimizing the potential to occlude the coronary
artery.
SUMMARY OF THE INVENTION
Embodiments hereof relate to a guide extension catheter including a
proximal shaft, a distal shaft, and a plurality of perfusion
openings. The distal shaft includes a jacket and a helical coil
structure embedded in the jacket, the distal jacket defining a
lumen. The plurality of perfusion openings are disposed through the
jacket of the distal shaft between windings of the helical coil
structure. The guide extension catheter is configured to extend
through a guide catheter and provide additional back support to the
guide catheter. The plurality of perfusion openings are configured
to allow fluid communication between an area outside the guide
extension catheter and the lumen of the guide extension
catheter.
Embodiments hereof also relate to a guide extension catheter
including a proximal shaft, a distal shaft, and a plurality of
perfusion openings. The distal shaft includes a jacket and a
braided structure embedded in the jacket, the distal shaft defining
a lumen. The braided structure includes a plurality of wire members
woven together to form the braided structure. The plurality of
perfusion openings are disposed through the jacket of the distal
shaft between the wire members of the braided structure. The guide
extension catheter is configured to extend through a guide catheter
and provide additional back support to the guide catheter. The
plurality of perfusion openings is configured to allow fluid
communication between an area outside the guide extension catheter
and the lumen of the guide extension catheter.
Embodiments hereof also relate to a guide extension catheter
including a proximal shaft and a distal shaft. The distal shaft
includes a braided jacket including a plurality of woven wire
members, the distal shaft defining a lumen. The plurality of wire
members are woven together such that a plurality of perfusion
openings are formed between the wire members, wherein the plurality
of perfusion openings extend from an outer surface of the distal
shaft to a lumen of the distal shaft. The guide extension catheter
is configured to extend through a guide catheter and provide
additional back support to the guide catheter. The plurality of
perfusion openings are configured to allow fluid communication
between an area outside the guide extension catheter and the lumen
of the guide extension catheter.
BRIEF DESCRIPTION OF DRAWINGS
The foregoing and other features and advantages of the invention
will be apparent from the following description of embodiments
hereof as illustrated in the accompanying drawings. The
accompanying drawings, which are incorporated herein and form a
part of the specification, further serve to explain the principles
of the invention and to enable a person skilled in the pertinent
art to make and use the invention. The drawings are not to
scale.
FIG. 1 is a side view illustration of a guide extension catheter in
accordance with an embodiment hereof.
FIG. 2 is a side view illustration of the guide extension catheter
of FIG. 1 extending through a guide catheter and disposed within a
coronary artery.
FIG. 2A is an illustration of a distal portion of the guide
extension catheter of FIG. 1 extending through a distal portion of
a guide catheter.
FIG. 3 is an exploded perspective illustration of an embodiment of
a distal shaft of the guide extension catheter of FIG. 1.
FIG. 4 is a perspective illustration of the distal shaft of the
guide extension catheter of FIG. 1.
FIG. 5 is a perspective illustration of a portion of a guide
extension catheter in accordance with another embodiment
hereof.
FIG. 6 is an exploded perspective illustration of the distal shaft
of the guide extension catheter of FIG. 5.
FIG. 7 is a perspective illustration of an embodiment of the
perfusion openings of the distal shaft of the guide extension
catheter of FIG. 1.
FIG. 8 is a perspective illustration of another embodiment of the
perfusion openings of the distal shaft of the guide extension
catheter of FIG. 1.
FIG. 9 is a perspective illustration of another embodiment of the
perfusion openings of the distal shaft of the guide extension
catheter of FIG. 1.
FIG. 10 is a perspective illustration of another embodiment of the
perfusion openings of the distal shaft of the guide extension
catheter of FIG. 1.
FIG. 11 is a perspective illustration of another embodiment of the
perfusion openings of the distal shaft of the guide extension
catheter of FIG. 1.
FIG. 12 is a perspective illustration of another embodiment of the
perfusion openings of the distal shaft of the guide extension
catheter of FIG. 1.
FIG. 13 is a perspective illustration of another embodiment of the
perfusion openings of the distal shaft of the guide extension
catheter of FIG. 1.
FIG. 14 is a perspective illustration of another embodiment of the
perfusion openings of the distal shaft of the guide extension
catheter of FIG. 1.
FIG. 15 is a perspective illustration of another embodiment of the
perfusion openings of the distal shaft of the guide extension
catheter of FIG. 1.
FIG. 16 is a perspective illustration of another embodiment of the
perfusion openings of the distal shaft of the guide extension
catheter of FIG. 1.
FIG. 17 is a perspective illustration of a portion of a guide
extension catheter in accordance with another embodiment
hereof.
FIG. 18 is a close-up view of a portion of the distal shaft of the
guide extension catheter of FIG. 17.
FIG. 19 shows a screen capture of an image of a portion of the
vasculature of a swine used in an animal trial.
FIG. 20 shows blood pressuring readings taken during an animal
trial using a conventional guide extension catheter and using a
guide extension catheter with perfusion openings.
DETAILED DESCRIPTION
Specific embodiments of the present invention are now described
with reference to the figures, wherein like reference numbers
indicate identical or functionally similar elements. The terms
"distal" and "proximal", when used in the following description to
refer to a guidewire, catheter, and/or other system component
hereof are with respect to a position or direction relative to the
treating clinician. Thus, "distal" and "distally" refer to
positions distant from, or in a direction away from the treating
clinician, and the terms "proximal" and "proximally" refer to
positions near, or in a direction toward the clinician. The terms
"distal" and "proximal", when used in the following description to
refer to a native vessel or native valve are used with reference to
the direction of blood flow from the heart. Thus, "distal" and
"distally" refer to positions in a downstream direction with
respect to the direction of blood flow and the terms "proximal" and
"proximally" refer to positions in an upstream direction with
respect to the direction of blood flow.
The following detailed description is merely exemplary in nature
and is not intended to limit the invention or the application and
uses of the invention. Furthermore, there is no intention to be
bound by any expressed or implied theory presented in the preceding
technical field, background, brief summary, or the following
detailed description.
FIGS. 1-5 illustrate a guide extension catheter 100 in accordance
with an embodiment hereof. The guide extension catheter 100, as
shown in FIG. 1, includes a proximal shaft 102 and a distal shaft
104 coupled to each other at a transition joint 103. The distal
shaft 104 includes a plurality of perfusion openings 106, as
described in greater detail below. The guide extension catheter 100
is configured for advancement through a guide catheter 108, as
shown in FIG. 2. The guide extension catheter 108 is further
configured to be seated within a coronary artery 1500 such that the
guide extension catheter 100 provides additional back support to
the guide catheter 108. The guide extension catheter 100 is further
configured such that the plurality of perfusion openings 106
provide blood flow to the coronary artery 1500 and permit blood
flow into the lumen of the guide extension catheter such that blood
pressure propagates through the fluid column of the guide catheter
108 for the AO blood pressure measurements. In an embodiment, the
guide extension catheter 100 may be between 20 cm and 40 cm in
length, with 4 cm-6 cm disposed within the coronary artery 1500,
but this is not meant to limit the design and a longer or shorter
guide extension catheter 100 may be utilized.
The proximal shaft 102, which may also be referred to as a push
member, may be a wire, hypotube, shaft, partial shaft, or any other
configuration as would be apparent to those skilled in the art. The
proximal shaft 102 includes a proximal end 112 and a distal end
114, as shown in FIG. 1. The distal end 114 of the proximal shaft
102 is coupled to a proximal end 116 of the distal shaft 104 at the
transition joint 103. The proximal shaft 102 is configured to
transfer motion applied at the proximal end 112 to the distal end
114. The proximal shaft is further configured to transfer motion of
the distal end 114 to the transition joint 103. The proximal shaft
102 may be formed of materials such as, but not limited to
stainless steel, Nitinol, or other materials suitable for the
purposes disclosed herein.
In an embodiment, the transition joint 103 is the proximal portion
of the distal shaft 104. In an embodiment, the transition joint is
formed by overlapping the distal end 114 of the proximal shaft 102
and the proximal end 116 of the distal shaft 104, as shown in FIG.
1. In other embodiments, the transition joint 103 may be formed of
different materials than the distal shaft 104. In some embodiments,
the transition joint 103 may be stiffer than the distal shaft 104.
For example, and not by way of limitation, the transition joint 103
may be a stainless steel tube embedded between an inner liner 121
and an outer jacket 118, as described in more detail below
regarding the distal shaft 104. The transition joint 103 defines a
lumen 125, therethrough. The transition joint 103 is configured to
couple the proximal shaft 102 to the distal shaft 104 such that
motion of the proximal shaft 102 is transferred to the distal shaft
104. The transition joint 103 may also transition from the stiff
proximal shaft 102 to the more flexible distal shaft 104.
In an embodiment, the distal shaft 104 includes an inner liner 121,
an outer jacket 118 and a helical coil structure 120 embedded
therebetween, as shown in of FIG. 3. The distal shaft 104 further
includes the plurality of perfusion openings 106, as shown in FIG.
4. The distal shaft 104 further includes the proximal end 116 and a
distal end 122, and defines a lumen 124 therethrough, as shown in
FIGS. 3-4.
In an embodiment, the inner liner 121 of the distal shaft 104 is of
a generally tubular shape and forms an inner surface 136 of the
distal shaft 104, as shown in FIG. 3. The inner liner 121 is
configured to provide the distal shaft 104 with a low friction
inner surface such that interventional devices may be
advanced/retracted easily through the lumen 124. The inner liner
121 may be formed from materials such as, but not limited to
polytetrafuoroethylene (PTFE), perfluoroalkoxy alkanes (PFAs),
high-density polyethylene (HDPA), or other materials suitable for
the purposes described herein.
In an embodiment, the outer jacket 118 of the distal shaft 104 is
of a generally tubular shape and forms an outer surface 134 of
distal shaft 104, as shown in FIG. 3. The outer jacket 118 is
configured to provide flexibility to the distal shaft 104. The
outer jacket 118 may be formed from materials such as, but not
limited to, thermoplastic elastomers, such as but not limited to
polyether block amides (e.g. PEBAX.RTM., VESTAMID.RTM.), nylon, or
other materials suitable for the purposes described herein.
The helical coil structure 120 of the distal shaft 104 is a
generally tubular helically wound wire member 138 (also known as a
filament). In an embodiment, the helical coil structure 120 is
embedded between the inner liner 121 and the outer jacket 118, as
shown in FIG. 3. The helical coil structure 120 is configured to
provide strength and rigidity to the distal shaft 104. The helical
coil structure 120 may be bonded between the inner liner 121 and
the outer jacket 118 by methods such as, but not limited to heat,
fusion, adhesives, or other methods suitable for the purposes
described herein. While the distal shaft 104 of FIGS. 3-4 shows the
helical coil structure 120 with only one (1) wire member 138, this
is not meant to limit the design, and more than one (1) wire member
138 may be utilized. Moreover, the wire member(s) 138 may be wound
(coiled) in differing patterns. The helical coil structure 120 may
be formed from materials such as, but not limited to, stainless
steel, Nitinol, or other materials suitable for the purposes
described herein.
As described above, the distal shaft 104 of the guide extension
catheter 100 includes perfusion openings 106 disposed therethrough.
Each perfusion opening 106 is an aperture extending from the outer
surface 134 to the inner surface 136 of distal shaft 104. Each
perfusion opening 106 is configured to allow fluid flow from/to an
area outside the distal shaft 104 to/from the lumen 124 of the
distal shaft 104. Each perfusion opening 106 is disposed through
the outer jacket 118 and the inner liner 121, between adjacent
windings of the helical coil structure 120, as shown in FIGS. 2A
and 4. Each perfusion opening 106, so disposed, insures that no
sharp edge or wire component of helical coil structure 120 is
exposed. The perfusion openings 106 of distal shaft 104 provide
blood flow BF1 to the distal vasculature (FIG. 2A). Moreover, the
perfusion openings provide blood flow BF2 such that blood pressure
at the distal end of the guide catheter 108 is transferred along
the fluid column to the pressure sensor at the hub of the guide
catheter 108. With adequate distal blood flow provided by the guide
extension catheter 100, the interventional cardiologist has more
time to complete the procedure with less chance of adverse
consequences.
The perfusion openings 106 shown in FIGS. 1-4 may be configured
with a shape, such as, but not limited to circles, ellipses, slits,
or any other shapes suitable for the purposes described herein.
Further, all the perfusions openings 106 do not need to be the same
shape or size. Additionally, the perfusion openings 106 may be
placed at various locations along the distal shaft 104, as
described in greater detail below. Each perfusion opening 106 may
be formed by methods such as, but not limited to, laser cutting,
mechanical punching, or other methods suitable for the purposes
described herein. As described above, the perfusion openings 106
are disposed between windings of the wire member 138 of the helical
coil structure 120. In practice, the spaces between the windings of
the helical coil structure are very small (the drawings are not to
scale). Therefore, the perfusion openings 106 must be formed very
precisely in order to avoid the windings of the helical coil
structure 120.
As shown in FIG. 2, the guide extension catheter 100 is configured
to provide additional back support to the guide catheter 108. A
distal end 126 of the guide catheter 108 is disposed within the
ostium 1502 of the coronary artery 1500. The distal shaft 104 of
the guide extension catheter 100 is disposed with a proximal
portion 128 within the guide catheter 108 and a distal portion 130
extending distally from the distal end 126 of the guide catheter
108. The distal portion 130 of the guide extension catheter 100 is
seated within the coronary artery 1500. With the guide extension
catheter 100 so disposed, the guide extension catheter 100 adds
back support to the existing back support of the guide catheter
108. With the additional back support of the guide extension
catheter 100, interventional devices, such as stents and guidewires
may be passed through the stenosis 1504 without unseating the guide
catheter 108 from the ostium 1502 of the coronary artery 1500.
FIGS. 5-6 show another embodiment of a guide extension catheter 200
including a proximal shaft 202, a distal shaft 204, a transition
joint 203 coupling the proximal shaft 202 to the distal shaft 204,
and a plurality of perfusion openings 206 disposed through the
distal shaft 204. The guide extension catheter 200 is similar to
the guide extension catheter 100. Therefore, details of the
construction and alternatives will not be repeated. The distal
shaft 204 of guide extension catheter 200 is similar to the distal
shaft 104 of the guide extension catheter 100. However, instead of
the helical coil structure 120, the distal shaft 204 includes a
braided structure 220 embedded between an inner liner 221 and an
outer jacket 218, as shown in FIG. 6. The inner liner 221 may be
similar to the inner liner 121 and the outer jacket 218 may be
similar to the outer jacket 118.
The braided structure 220 may be formed by weaving together two
continuous wire members 238 in opposite directions in a
one-over-one pattern, as shown in FIG. 6. While the distal shaft
204 of FIGS. 5-6 shows braided structure 220 with only two wire
members 238, this is not meant to limit the design, and more than
two wire members 238 may be utilized. Moreover, while FIG. 6 shows
wire members 238 braided in a one-over-one pattern, this is not
meant to limit the design, and the wire members 238 may be woven in
differing patterns.
The distal shaft 204 includes a plurality of perfusion openings
206. The perfusions openings 206 are similar to the perfusion
openings 106 of FIGS. 1-4 and therefore will not be described in
detail. As with the perfusion openings 106, the perfusion openings
206 extend from an outer surface 234 of the distal shaft 204 to a
lumen 224 of the distal shaft 204. Further, the perfusion openings
206 are formed between the wire members 238 of the braided
structure 220.
With the above understanding of examples of guide extension
catheters 100, 200, FIGS. 7-16 show various embodiments of the
shape, size, and distribution of the plurality of perfusion
openings 106, 206. The descriptions of FIGS. 7-16 are made with
reference to the distal shaft 104 of FIGS. 1-4 for convenience. The
details of the plurality of perfusion openings of each embodiment
apply equally to other embodiments disclosed herein. Further,
various modifications to the number and specific distribution
arrangement of the embodiments of FIGS. 7-16 may be made within the
scope of the present invention. Additionally, the sizes, shapes,
patterns, and distributions of FIGS. 7-16 may be utilized together
in any combination, with the specific configuration optimized for
specific treatment purposes.
FIG. 7 shows an example of a circular perfusion opening 106.
Although only one perfusion opening 106 is shown in FIG. 7, the
description below can apply to a plurality of the perfusion
openings 106. The perfusion opening 106 of FIG. 7 is circular and
has a diameter D1. The diameter D1 may be between 0.01 mm and 0.5
mm such that a 0.014'' guidewire cannot pass through any of the
perfusion openings 106. This, reduces the potential risk of the
guidewire exiting through a perfusion opening 106 and dissecting or
otherwise damaging an adjacent artery.
FIG. 8 shows an example of an elliptical perfusion opening 106.
Although only one perfusion opening 106 is shown in FIG. 8, the
description below can apply to a plurality of the perfusion
openings 106. The elliptical perfusion opening 106 has a major axis
M1 and a minor axis M2. In an embodiment, the major axis M1 may be
between 0.01 mm and 0.5 mm and the minor axis M2 may be between
0.01 mm and 0.5 mm such that a 0.014'' guidewire cannot pass
through any of the perfusion openings 106. This reduces the
potential risk of the guidewire exiting through a perfusion opening
106 and dissecting or otherwise damaging an adjacent artery. The
elliptical shape of the perfusion openings 106 of FIG. 8 may
optimize flow volume while minimizing the dimension in the
longitudinal direction of the distal shaft. Additionally, the
elliptical shape may be configured to cover a greater area of the
outer surface 134 of the distal shaft 104, thereby capturing a
greater volume of blood flow. The elliptical shape also allows the
perfusion openings to cover a greater amount of surface area
without compromising the helical coil structure 120. Further, while
the perfusion opening 106 of FIG. 8 is described as elliptical, it
need not be a perfect ellipse. Instead, for example, it can be
generally oval in shape.
FIG. 9 shows an embodiment with an isolated perfusion opening 106.
By an isolated perfusion opening 106, it is meant that the
perfusion opening is located at a specific location along the
distal shaft 104 for a particular reason. For example, and not by
way of limitation, the isolated perfusion opening may be located to
provide perfusion to a branch vessel. Accordingly, a plurality of
isolated perfusion openings 106 may be provided at specific
locations to perfuse different branch vessels. Further, the
isolated perfusion openings 106 may be used in combination with
other embodiments described herein, wherein the distribution of the
perfusion openings 106 serves a different purpose.
FIG. 10 shows an embodiment with a plurality of the perfusion
openings 106 located adjacent to each other in the same space 121
between adjacent windings of the helical coil structure 120. FIG.
10 shows two perfusion openings 106 co-located in the space 127
between adjacent windings of the helical coil structure 120, but
more openings 106 can be co-located depending on the space
available. Further, FIG. 10 shows only two perfusion openings 106.
However, other perfusion openings 106 may be provided along the
length of the distal shaft (either co-located or not) in accordance
with other embodiments described herein. Locating multiple
perfusion openings 106 closely adjacent to each other, as shown in
FIG. 10, provides increased blood flow (perfusion) to/from the
lumen 124 of the distal shaft 104 at specific locations.
FIG. 11 shows an embodiment with a plurality of the perfusion
openings 106 concentrated at a location along the distal shaft 104.
In the embodiment shown in FIG. 11, four perfusion openings 106 are
concentrated near each other. However, more or fewer perfusion
openings 106 may be concentrated at a location near each other.
Further, additional perfusion openings 106 may be provided
elsewhere along the distal shaft 104, as described in other
embodiments. The concentrated distribution of the perfusion
openings is configured to provide a bolus of oxygenated blood
through the distal shaft 104 to arteries distal of the guide
extension catheter 100.
FIG. 12 shows an embodiment with a plurality of the perfusion
openings 106 spaced from each other by a single winding of the
helical coil structure 120. In the embodiment of FIG. 12, the
perfusion openings 106 are also aligned along a common longitudinal
axis LA. By providing the plurality of perfusion openings along the
longitudinal axis LA, flexibility of the distal shaft 104 is
increased in the direction of the plurality of openings 106 as
compared to the side of the distal shaft 204 which is opposite the
plurality of openings 106. However, the plurality of openings 106
also increases flexibility of the distal shaft 104 in all
directions as compared to the same shaft without the plurality of
openings. FIG. 13 shows a similar embodiment with the plurality of
openings 106 aligned along a common longitudinal axis LA, but with
adjacent perfusion openings 106 spaced from each other by two
windings of the helical coil structure 120. The alternate-winding
spaced distribution of the perfusion openings 106 provides
increased flexibility to the distal shaft 104, but the flexibility
is less than the embodiment of FIG. 12 due to the alternate-winding
spaced distribution.
FIG. 14 shows an embodiment with the plurality of perfusion
openings 106 arranged spirally around a central longitudinal axis
LA of the distal shaft 104. The spiral distribution of the
perfusion openings is configured to increase overall flexibility of
the distal shaft 104 without biasing the flexibility of the distal
shaft 104 in any one direction. The concentration of the perfusion
openings 106 along the spiral distribution may be increased or
decreased to increase or decrease flexibility of the distal shaft
104.
FIG. 15 shows an embodiment with the plurality of perfusion
openings 106 disposed on opposing sides of the distal shaft 104. In
the embodiment of FIG. 15, the perfusion openings 106 are disposed
along a first longitudinal axis (not shown for clarity) and the
perfusion openings 106' are disposed along a second longitudinal
axis (not shown for clarity) that is spaced 180 degrees from the
first longitudinal axis around the circumference of the distal
shaft 104. The plurality of perfusion openings 106, 106' generally
increase flexibility of the distal shaft. Further, the distribution
of the plurality of perfusion openings 106, 106' longitudinally
along opposite walls of the distal shaft specifically increases
flexibility of the distal shaft 104 in the direction of each wall
with the perfusion openings 106, 106' (i.e., into and out of the
paper in FIG. 15) as compared to the directions without the
perfusion openings (i.e., up a down in FIG. 15).
FIG. 16 shows an embodiment with a greater concentration of the
plurality of perfusion openings 106 at a distal portion 130 near
the distal end 122 of the distal shaft 104 than a proximal portion
of the distal shaft 104. By providing more of the perfusion
openings 106 at the distal portion 130 of the distal shaft 104, the
flexibility of the distal shaft 104 increases at the distal portion
130. Increased flexibility near the distal end 122 provides a
softer distal portion 130, increasing deliverability and reducing
potential damage to adjacent tissue as the distal shaft 104 is
advanced. The embodiment of FIG. 16 shows perfusion openings 106
proximal of the distal portion 130. However, the proximal perfusion
openings can be omitted. In other similar embodiments, the
concentration of perfusion openings gradually increases from a
proximal portion of the distal shaft 104 to a distal portion of the
proximal shaft 104, thereby gradually increasing the flexibility of
the distal shaft 104 toward the distal portion.
FIGS. 17-18 show another embodiment of a guide extension catheter
300. Guide extension catheter 300 includes a proximal shaft 302, a
distal shaft 304, and a transition joint 303 coupling the proximal
shaft 302 and the distal shaft 304. The proximal shaft 302 and the
transition joint 303 may be similar to the proximal shaft 102 and
the transition joint 103 described above, and therefore are not
described in detail with respect to FIGS. 17-18.
The distal shaft 304 of the guide extension catheter 300 includes a
braided jacket 318 and a distal tip 340, as shown in FIG. 17. The
distal shaft 304 further includes a plurality of perfusion openings
306 formed by the braided jacket 318, as described in greater
detail below. The distal shaft 304 defines a lumen 324 extending
from a proximal end 316 to a distal end 322 of the distal shaft.
The guide extension catheter 300 is configured to provide
additional back support to a guide catheter (not shown in FIG. 19)
similar to the guide extension catheters 100, 200, described
previously.
The braided jacket 318 of the distal shaft 304 includes a plurality
of wire members 338 woven to form a generally tubular shape, as
shown in FIGS. 17-18. The braided jacket 318 is configured to
provide flexibility, strength, and rigidity to the distal shaft
304. Moreover, the braided jacket 318 forms the plurality of
perfusion openings 306 between the adjacent woven wire members 338.
The perfusion openings 306 extend from an outer surface to the
lumen 324 of the distal shaft 304. The weave of the braided jacket
318 should be tight enough to maintain structural integrity of the
distal shaft 304, but not too tight such that the distal shaft 304
becomes inflexible and/or the adjacent wire members 338 occlude the
corresponding perfusion openings 306. The braided jacket 318 is
formed by weaving together the plurality of wire members 338 in
opposite directions in a one-over-one pattern. The weaving pattern,
number and size of the wire members 338 may be varied. The wire
members 338 of the braided jacket 318 may be formed from materials
such as, but not limited to, stainless steel, Nitinol, or other
materials suitable for the purposes described herein.
In an embodiment, the distal shaft 304 includes the distal tip 340,
as shown in FIG. 17. The distal tip 340 is disposed at the distal
end 322 of the distal shaft 304. The distal tip 340 is configured
to provide a soft distal end to the distal shaft 304 such that the
distal shaft 1404 does not damage the surrounding tissue as the
distal shaft 304 is advanced through the vasculature of the
patient. The distal tip 340 may be formed from materials such as,
but not limited to, polymers, or other materials suitable for the
purposes described herein. The distal tip 340 may be coupled to the
braided jacket 318 of the distal shaft 304 in a manner such as, but
not limited to adhesives, fusing, welding, or other methods
suitable for the purposes disclosed herein.
Each perfusion opening 306 may be defined by the edges of adjacent
woven wire members 338 forming the perfusion opening 306. In the
embodiment shown in FIGS. 17-18, each perfusion opening 306 is a
quadrilateral. Further, each perfusion opening in FIGS. 17-18 is
the same size and shape. However, this is not meant to limit the
design, and the weave pattern and tightness of the weave of the
braided jacket 318 may be altered in any combination such that the
perfusion openings 306 are not uniform. Further, changes in the
weave pattern and tightness of the weave of the braided jacket 318
may also change the flexibility of the distal shaft 304. For
example, and not by way of limitation, the weave pattern of the
wire members 338 may be loosened towards the distal portion of the
distal shaft 304, thereby increasing the flexibility of the distal
portion of the distal shaft 304 and increasing the size of the
perfusion openings 306 towards the distal portion of the distal
shaft.
In an embodiment, the plurality of wire members 338 of the braided
jacket 318 of the distal shaft 304 may include a coating on an
outer surface and/or an inner surface thereof. The coating disposed
on the outer surface of the plurality of wire members 338 may
reduce the surface friction between the distal shaft 304 and the
guide catheter or vasculature as the distal shaft 304 is advanced
through the vasculature. Additionally, the coating disposed on the
inner surface may allow interventional devices to be
advanced/retracted more easily within the lumen 324 of the distal
shaft 304. The coating is preferably applied to the plurality of
wire members 338 prior to weaving the plurality of wire members 338
to form the braided jacket 318. In this manner, the perfusion
openings 306 are not blocked by a post-weaving coating. However, a
post-weaving coating may be applied provided that the perfusion
openings 306 are not blocked by the coating. The coating may be a
polymer, such as polyether block amides (e.g. PEBAX.RTM.,
VESTAMID.RTM.), nylon, or any other materials suitable for purposes
of the present disclosure. In some embodiments, the coating may be
a lubricious coating.
As noted in the Background section above, it has been discovered by
the inventors hereof that using conventional guide extension
catheters without perfusion openings may disrupt blood flow distal
of the guide extension catheter. This disruption of blood flow is
indicated by a dampened AO pressure reading. This disruption may
result in insufficient blood flow to arteries distal of the
conventional guide extension catheter. FIGS. 19-20 show results of
an animal trial showing how the present invention alleviates the
discovered problems with conventional guide extension catheters. In
particular, FIG. 19 shows a screen capture of a cine image. FIG. 19
shows a guide extension catheter 400 disposed through a guide
catheter, and deep seated into the first diagonal off of the left
anterior descending artery (LAD) in a porcine model. A pressure
wire 402 (i.e., a guidewire with a pressure sensor at a distal tip
thereof, also known as an FFR wire) is extended through the guide
extension catheter with the distal tip of the pressure wire
extending distal of the distal tip of the guide extension catheter.
The pressure wire measures arterial pressure in the vessel distal
to the guide extension catheter. An AO pressure sensor measures the
pressure at the hub of the guide catheter which is transferred
though the column of blood in the guide catheter. The set-up
described above with respect to FIG. 19 was done with a
conventional guide extension catheter without perfusion openings
(GuideLiner.RTM. guide extension catheter, Vascular Solutions,
Inc.) and with a prototype guide extension catheter including
perfusion openings, as described above.
FIG. 20 shows in a single graph the results of the pressure wire
and AO pressure readings for the trial using a conventional guide
extension catheter without perfusion openings (lines 410, 412) and
a guide extension catheter including perfusion openings (lines 420,
422). While these results are shown in a single graph for easy
comparison, the test for each was conducted at different times. As
can be seen in FIG. 20, the blood pressure readings with the
pressure wire and AO pressure sensor (420, 422) when using the
perfusion guide extension catheter of the present disclosure are in
the normal range for blood pressure readings. When using a
conventional guide extension catheter without perfusion openings,
the blood pressure readings with both the pressure wire and the AO
pressure sensor (410, 412) are dampened. As can be seen, the
systolic and diastolic pressures are both under 20 mmHg, and the
readings appear closer to a line rather than a wave. In this
situation (use of a conventional guide extension catheter), the
hemodynamic system was not able to identify the systolic and
diastolic portions of the wave because of the dampening. These
results show that using a conventional guide extension catheter
without perfusion openings causes disruption of the blood flow
distal of the guide catheter. Therefore, the AO pressure
measurement is dampened due to the disruption of blood flow.
Further, these results show that when using a conventional guide
extension catheter, insufficient blood flow is reaching arteries
distal of guide extension catheter, thereby endangering the
patient. These results further show that the use of a guide
extension catheter according to the present disclosure (with
perfusion holes) dramatically improves blood flow for the AO
pressure measurement. Further, the dramatically improved distal
pressure measurement shows dramatic improvement in blood flow
distal of the inventive guide extension catheter.
While only some embodiments have been described herein, it should
be understood that it has been presented by way of illustration and
example only, and not limitation. Various changes in form and
detail can be made therein without departing from the spirit and
scope of the invention, and each feature of the embodiments
discussed herein, and of each reference cited herein, can be used
in combination with the features of any other embodiment. All
patents and publications discussed herein are incorporated by
reference herein in their entirety.
* * * * *